17-alpha Hydroxyprogesterone caproate did not reduce the rate of recurrent preterm birth in a prospective cohort study.

BACKGROUND: 17-alpha Hydroxyprogesterone caproate for prevention of recurrent preterm birth is recommended for use in the United States. OBJECTIVE: We sought to assess the clinical effectiveness of 17-alpha hydroxyprogesterone caproate to prevent recurrent preterm birth ≤35 weeks compared to similar births in our obstetric population prior to the implementation of 17-alpha hydroxyprogesterone caproate. STUDY DESIGN: This was a prospective cohort study of 17-alpha hydroxyprogesterone caproate in our obstetric population. The primary outcome was the recurrence of birth ≤35 weeks for the entire study cohort compared to a historical referent rate of 16.8% of recurrent preterm birth in our population. There were 3 secondary outcomes. First, did 17-alpha hydroxyprogesterone caproate modify a woman's history of preterm birth when taking into account her prior number and sequence of preterm and term births? Second, was recurrence of preterm birth related to 17-alpha hydroxyprogesterone caproate plasma concentration? Third, was duration of pregnancy modified by 17-alpha hydroxyprogesterone caproate treatment compared to a prior preterm birth? RESULTS: From January 2012 through March 2016, 430 consecutive women with prior births ≤35 weeks were treated with 17-alpha hydroxyprogesterone caproate. Nearly two thirds of the women (N = 267) began injections ≤18 weeks and 394 (92%) received a scheduled weekly injection within 10 days of reaching 35 weeks or delivery. The overall rate of recurrent preterm birth was 25% (N = 106) for the entire cohort compared to the 16.8% expected rate (P = 1.0). The 3 secondary outcomes were also negative. First, 17-alpha hydroxyprogesterone caproate did not significantly reduce the rates of recurrence regardless of prior preterm birth number or sequence. Second, plasma concentrations of 17-alpha hydroxyprogesterone caproate were not different (P = .17 at 24 weeks; P = .38 at 32 weeks) between women delivered ≤35 weeks and those delivered later in pregnancy. Third, the mean (±SD) interval in weeks of recurrent preterm birth before 17-alpha hydroxyprogesterone caproate use was 0.4 ± 5.3 weeks and the interval of recurrent preterm birth after 17-alpha hydroxyprogesterone caproate treatment was 0.1 ± 4.7 weeks (P = .63). A side effect of weekly 17-alpha hydroxyprogesterone caproate injections was an increase in gestational diabetes. Specifically, the rate of gestational diabetes was 13.4% in 17-alpha hydroxyprogesterone caproate-treated women compared to 8% in case-matched controls (P = .001). CONCLUSION: 17-alpha Hydroxyprogesterone caproate was ineffective for prevention of recurrent preterm birth and was associated with an increased rate of gestational diabetes.

Oxytocin preparation stability in several common obstetric intravenous solutions.

OBJECTIVE: The purpose of this study was to determine the stability of oxytocin in lactated Ringer's solution and lactated Ringer's-dextrose 5% solution over a 24-hour period at 25 degrees C and over a 7-day period at 5 degrees C. STUDY DESIGN: Twenty units (2.1 microg equal 1 unit) of oxytocin were injected into 1000 mL of lactated Ringer's solution and lactated Ringer's-dextrose 5% solution. Samples for the analysis were drawn at specified times after storage at 5 degrees C and 25 degrees C. These samples were stored at -70 degrees C for later analysis. Statistical analysis was done with 1-way analysis of variance and Tukey-Kramer multiple comparisons. RESULTS: Twenty units of oxytocin in 1000 mL of lactated Ringer's solution and lactated Ringer's-dextrose 5% solution was found to be stable for 7 days at 5 degrees C and for 24 hours at 25 degrees C. CONCLUSION: Premixed oxytocin solutions in lactated Ringer's solution and lactated Ringer's-dextrose 5% solution are stable in conditions commonly found in dispensing pharmacies and labor and delivery units. This finding could lead to the more efficient use of personnel during the mixing process, could provide solutions that are aseptically prepared, and could be a tool to reduce costs and improve patient care.